Study on the Health Economic Burden of Alzheimer's Disease in China

NCT05995418 | Unknown

• 1 other identifier: 2023132
• Study Type: observational
• Target: 9,510
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center and cross-sectional study. Using standardized case report forms, we randomly selected suitable patients from the cognitive centers of provincial administrative units in Chinese mainland to conduct a questionnaire survey, so as to obtain relevant information about their economic burden.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• Direct medical expenses

  Direct medical expenses refer to the expenses incurred by patients and/or their families for medical and health services related to Alzheimer's disease

  baseline

• Direct non-medical expenses

  The direct non-medical costs of Alzheimer's disease include care costs, home facilities and repair costs, health care products costs and related expenses incurred during medical treatment. The cost of care includes the salary of caregivers, the expenses of external caregivers, and the travel expenses of caregivers

  baseline

• overhead expenses

  Indirect costs include the economic loss caused by patients' inability to work, the decrease in the income of informal caregivers, the treatment expenses of caregivers' psychological diseases and the medical expenses incurred by patients with Alzheimer's disease or caregivers due to accidental injuries.

  baseline

Study Arms (3)

amnestic mild cognitive impairment(aMCI）

1. aMCI diagnostic criteria of National Institute of Aging and National Association of Alzheimer's Disease (NIA-AA). 2. The ClinicalDementiaRating scale (CDR) is 0.5. 3. Mini-MentalStateExamination (MMSE): MMSE≥17 for those with 0 years of education, ≥20 for those with less than 7 years, and ≥24 for those with more than 7 years. 4. Memory impairment is prominent, and it may also be accompanied by functional impairment of other cognitive domains. 5. The onset is insidious and the progress is slow. 6. Not up to the level of dementia

Other: There was no intervention as this was an observational study.

mild to moderate AD

Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.

Other: There was no intervention as this was an observational study.

severe AD

Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.

Other: There was no intervention as this was an observational study.

Interventions

There was no intervention as this was an observational study. OTHER

There was no intervention as this was an observational study.

amnestic mild cognitive impairment(aMCI）; mild to moderate AD; severe AD

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research center samples 192 cognitive centers selected by the National Health and Wellness Commission's Capacity Building and Continuing Education for Cognitive Impairment Diseases Project in 2022.

You may qualify if:

• Criteria for selection of centers The study center sample relied on the 192 cognitive centers selected for the 2022 National Health and Health Commission Capacity Building and Continuing Education for Cognitive Impairment Disease Specialty Capacity Building Program.
• The study covered all 31 provincial administrative units in mainland China, divided according to east, center, and west:
• East: Hebei, Beijing, Tianjin, Shandong, Jiangsu, Shanghai, Zhejiang, Fujian, Guangdong, Hainan, Heilongjiang, Jilin, and Liaoning; Central: Henan, Hubei, Hunan, Anhui, Jiangxi, Shanxi; West: Chongqing, Sichuan, Yunnan, Guizhou, Tibet, Shaanxi, Gansu, Qinghai, Xinjiang, Ningxia, Inner Mongolia, Guangxi.

You may not qualify if:

• Compliance with Peterson's aMCI diagnostic criteria National Institute on Aging and Alzheimer's Disease Association (NIA-AA) aMCI diagnostic criteria in 2004 \[7\].
• Clinical Dementia Rating (CDR) of 0.5.
• Mini-Mental State Examination (MMSE): ≥17 points on MMSE for those with 0 years of education, ≥20 points for those with less than 7 years, and ≥24 points for those with greater than or equal to 7 years.
• Memory loss is prominent and may also be accompanied by impairment of other cognitive domains.
• Insidious onset and slow progression.
• Meets the core clinical criteria for probable AD dementia in the 2011 NIA-AA Revised Diagnostic Criteria for AD. \[7\]
• Can be categorized as having mild, moderate, or severe Alzheimer's disease.
• Mild: progressive cognitive impairment affecting multiple domains and psychobehavioral deficits; significant impact on daily life, primarily impairing instrumental activities, no longer fully independent, occasionally requiring assistance; or a CDR score of 1.0
• Moderate: progressive cognitive impairment and psychobehavioral changes; extensive impact on daily life, partial impairment of basic functioning, inability to live independently, frequent need for assistance; or CDR 2.0 score
• Severe: progressive cognitive impairment and psychobehavioral changes, may not be able to conduct clinical interviews; severe impact on daily life, impairment of basic activities including self-care, total dependence on help; or CDR 3.0 points
• CDR greater than 0.5 points.
• MMSE: \<17 points for those with 0 years of education, \<20 points for those with less than 7 years, and \<24 points for those with greater than or equal to 7 years.
• Subject has good audiovisual and speech functions or can complete a neuropsychological examination with correction.
• The subject and the informant can complete relevant examinations and follow-up visits.
• Age not less than 60 years

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 16, 2023
• Study Start: July 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-05

Locations

CN (1)